NCT07186634

PeRiOperative Medicine Platform Trial

Domain-Specific Appendix: OXYGEN

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7,800 (estimated)
• Sponsor: Monash University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or "wound infections") and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases "days alive and at home up to 30 days after surgery" (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective surgery.

Detailed description

www.promptssi.org.au

Conditions

• Surgical Site Infection After Major Surgery
• Anaesthesia
• Major Complications
• Quality of Recovery (QoR-15)
• Quality of Life

Interventions

Type	Name	Description
DRUG	Liberal inspired oxygen	The concentration of Oxygen will differ according to the randomisation
DRUG	Conservative inspired oxygen	Conservative inspired oxygen
DRUG	Intermediate inspired oxygen	Intermediate inspired oxygen

Timeline

• Start date: 2026-04-06
• Primary completion: 2035-12-01
• Completion: 2035-12-01
• First posted: 2025-09-22
• Last updated: 2026-04-17

Locations

2 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study